S5 - E16.5 - From The Vault: Stephen Harrison Discusses FASCINATE-2 Results For Denifenstat

Surfing the MASH Tsunami

In this excerpt from last July, Stephen Harrison shares results of the FASCINATE-2 study as part of SurfingMASH's larger coverage of exciting drug trials presented at The EASL Congress.
The original writeup reads:

This month, Surfing NASH embarks on a series of episodes dedicated to takeaways emerging from June's two major conferences: the 2023 EASL Congress in Vienna and the American Diabetes Association's 83rd Scientific Sessions meeting in San Diego. This is the second session focusing on drug development, and specifically, on several presentations for exciting drugs in development. In doing so, the Big Band of Surfers (Stephen Harrison, Jörn Schattenberg, Louise Campbell and Roger Green) are joined by Mazen Noureddin for a fascinating conversation which covers plenty of compelling clinical trial data.
Jörn preludes this discussion by noting just how much important drug development research was released at this year's EASL Congress. Stephen proceeds from here to detail positive Phase 2b FASCINATE-2 clinical trial interim data for fatty acid synthase (FASN) inhibitor, denifanstat, as presented at EASL Congress by Rohit Loomba. In the process, Stephen elucidates why the idea of a FASN inhibitor is so exciting. It blocks de novo lipogenesis, which means it can have effects on inflammation and possibly direct fibrosis inhibition. Previously in Season 4, Episode 32, it was discussed why inflammation, which is tied to liver volume, might be a critical component to better understand for therapuetic development and the wider scope of liver health. From here, Stephen goes on to describe the trial, starting with basic design and sharing the MRI-PDFF and biomarker data that was presented at the EASL Congress. He finishes with safety and efficacy data and a general comment that the trial demonstrated, 'the drug is doing what it's intended.'